Agency Information Collection Activities; Proposed Collection; Comment Request; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing, 71621-71623 [2013-28599]
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Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Adverse Event Program for Medical
Devices (Medical Product Safety
Network)—(OMB Control Number
0910–0471)—Extension
Among other things, section 519 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360i)
authorizes FDA to require: (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions and (2) user facilities to
report device-related deaths directly to
manufacturers and FDA and serious
injuries to the manufacturer. Section
213 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
519(b) of the FD&C Act relating to
mandatory reporting by user facilities of
deaths, serious injuries, and serious
illnesses associated with the use of
medical devices. This amendment
legislated the replacement of universal
user facility reporting by a system that
is limited to a ‘‘. . . subset of user
facilities that constitutes a
representative profile of user reports’’
for device-related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act.
This legislation provides FDA with the
opportunity to design and implement a
national surveillance network,
composed of well-trained clinical
facilities, to provide high-quality data
on medical devices in clinical use. This
system is called the Medical Product
Safety Network (MedSun).
FDA is seeking OMB clearance to
continue to use electronic data
collection to obtain the information on
Form FDA 3500A (approved under
OMB control number 0910–0291)
related to medical devices and tissue
products from the user facilities
participating in MedSun, to obtain a
demographic profile of the facilities,
71621
and for additional questions which will
permit FDA to better understand the
cause of reported adverse events.
Participation in the program is
voluntary and currently includes 250
facilities.
In addition to collecting data on the
electronic adverse event report form,
MedSun collects additional information
from participating sites about reported
problems emerging from the MedSun
hospitals. This data collection is also
voluntary and is collected on the same
Web site as the report information.
The burden estimate is based on the
number of facilities currently
participating in MedSun (250). FDA
estimates an average of 15 reports per
site annually. This estimate is based on
MedSun working to promote reporting
in general from the sites, as well as
promoting reporting from specific parts
of the hospitals, such as the pediatric
intensive care units, the
electrophysiology laboratories, and the
hospital laboratories.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
No. of
respondents
No. of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
MedSun facilities participating in the electronic reporting of
adverse events program (Form FDA 3670) .....................
250
15
3,750
0.75
2,813
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28600 Filed 11–27–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1422]
sroberts on DSK5SPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Eye Tracking
Study of Direct-to-Consumer
Prescription Drug Advertisement
Viewing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
VerDate Mar<15>2010
17:56 Nov 27, 2013
Jkt 232001
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Eye Tracking Study
of Direct-to-Consumer Prescription Drug
Advertisement Viewing.’’ This study is
designed to use eye tracking technology
to explore how consumers view directto-consumer (DTC) prescription drug
advertisements (ads) that include text
regarding risk information and reporting
side effects and that vary in the amount
of distracting audio and visual content
during the presentation of the risk
information.
Submit either electronic or
written comments on the collection of
information by January 28, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
DATES:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
E:\FR\FM\29NON1.SGM
29NON1
71622
Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Eye Tracking Study of Direct-toConsumer Prescription Drug
Advertisement Viewing—(OMB Control
Number 0910–NEW)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(b)(2)(c))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
Current regulations require that a
major statement of the risks of
prescription drugs be included in at
least the audio of DTC television ads.
FDA has proposed including the risk
information in DTC television ads in
superimposed text as well as in the
audio (75 FR 15376, ‘‘Direct-toConsumer Prescription Drug
Advertisements; Presentation of the
Major Statement in Television and
Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner’’). In
addition, Title IX of the Food and Drug
Administration Amendments Act (Pub.
L. 110–85) required a study to
determine if the statement ‘‘You are
encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1–
800–FDA–1088’’ (the MedWatch
statement) is appropriate for inclusion
VerDate Mar<15>2010
17:56 Nov 27, 2013
Jkt 232001
in DTC television ads. These
communications have been tested
separately by FDA. The first study
found that participants were better able
to recall the drug risks when they were
presented in superimposed text as well
as in audio (OMB Control Number
0910–0634, ‘‘Experimental Evaluation of
the Impact of Distraction’’). The second
study found that the inclusion of the
MedWatch statement does not interfere
with participants’ understanding of the
risk information (OMB Control Number
0910–0652,‘‘Experimental Study: TollFree Number for Consumer Reporting of
Drug Product Side Effects in Direct-toConsumer Television Advertisements
for Prescription Drugs’’). Thus, these
two new communications may appear
in future DTC television ads. However,
they have not been examined together.
In addition, questions continue to
arise about the use of potentially
distracting images and sounds during
the major statement of risks in DTC
television ads. The first study
referenced above found no differences
among ads that differed in the affective
tone of static, non-moving visuals
presented during the major statement of
risks. Previous research has shown that
factors such as multiple scene changes
and music in advertising can be
distracting. However, the effects of this
kind of distraction during the major
statement of risks on consumers’
perceptions and risk recall has not been
tested in the presence of risk reinforcing
superimposed text.
This project is designed to use eye
tracking technology to determine how
these communications in DTC ads are
perceived and the impact of distraction.
Eye tracking technology is an effective
method to determine the extent to
which consumers attend to risk
information presented in DTC television
ads. This technology allows researchers
to unobtrusively detect and measure
where a participant looks while viewing
a television ad and for how long, and
the pattern of their eye movements may
indicate attention to and processing of
information in the ad.
We plan to collect descriptive eye
tracking data on participants’ attention
to (1) the superimposed text during the
major statement of risk information and
(2) the MedWatch statement. Further,
we plan to examine experimentally the
effect of distraction. We hypothesize
that distracting audio and visuals during
the major statement will decrease risk
recall, risk perceptions, and attention to
superimposed text risk information. To
test these hypotheses, we will conduct
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
inferential statistical tests such as
analysis of variance. With the sample
size described below, we will have
sufficient power to detect small- to
medium-sized effects in the main study.
We plan to conduct one 60-minute
pilot study with 30 participants and one
30-minute main study with 300
participants. All participants will be 18
years of age or older who self-identify as
needing to lose more than 30 pounds.
We will exclude individuals who work
in healthcare or marketing or who wear
bifocals or hard contact lenses. The
studies will be conducted in person in
at least five different cities across the
United States.
The pilot study and main study will
have the same design and will follow
the same procedure. Participants will be
randomly assigned to one of three test
conditions (low, medium, and high
distraction in a DTC television ad). The
ad will be for a fictitious weight loss
prescription drug. The ads are currently
being created and pretested to ensure
that consumers perceive different levels
of distraction across the ads (OMB
Control Number 0910–0695, ‘‘Stimuli
Development and Pretests for an
Attentional Effects Study’’). For
instance, as the distraction level
increases, the number of scene changes
and on-screen activity during the major
statement will increase.
We will explain the study procedure
to participants and calibrate the eye
tracking device. To collect eye tracking
data, we will use an unobtrusive
computer-interfaced eye tracker with a
minimum speed of 60 Hertz. The test
images will be shown on a computer
monitor with a minimum size of 20
inches and a minimum display
resolution of 1,280 × 1,024. To simulate
normal television ad viewing,
participants will watch a 2 to 5 minute
video clip followed by a series of three
ads. One of the ads will be the study ad.
The video clip and non-study ads will
be unrelated to health. The order of the
ads will be counterbalanced, and only
eye tracking data from the study ad will
be analyzed. Next, participants will
complete a questionnaire that assesses
risk perceptions, risk recall, recall of the
MedWatch statement, and covariates
such as demographics and health
literacy. In the pilot study, participants
will also answer questions as part of a
debriefing interview to assess the study
design and questionnaire. The
questionnaire is available upon request.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\29NON1.SGM
29NON1
71623
Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Eye tracking study of DTC prescription drug advertisement viewing
Number of
responses
per
respondent
Number of
respondents
Total
annual
responses
Average
burden per
response
Total hours
Pilot study screener .....................................................
Main study screener ....................................................
Pilot study ....................................................................
Main study ...................................................................
200
2,000
30
300
1
1
1
1
200
2,000
30
300
0.03 (2 minutes) .....
0.03 (2 minutes) .....
1 .............................
0.50 (30 minutes) ..
6
60
30
150
Total ......................................................................
........................
........................
........................
................................
246
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28599 Filed 11–27–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0716]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Designated New
Animal Drugs for Minor Use and Minor
Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
30, 2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0605. Also
SUMMARY:
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Designated New Animal Drugs for
Minor Use and Minor Species; 21 CFR
Part 516—(OMB Control Number 0910–
0605)—Extension
Description: The Minor Use and
Minor Species Animal Health Act of
2004 (MUMS) (Pub. L. 108–282)
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to
authorize FDA to establish new
regulatory procedures intended to make
more medications legally available to
veterinarians and animal owners for the
treatment of minor animal species as
well as uncommon diseases in major
animal species. This legislation
provides incentives designed to help
pharmaceutical companies overcome
the financial burdens they face in
providing limited-demand animal
drugs. These incentives are only
available to sponsors whose drugs are
‘‘MUMS-designated’’ by FDA. Minor use
drugs are drugs for use in major species
(cattle, horses, swine, chickens, turkeys,
dogs, and cats) that are needed for
diseases that occur in only a small
number of animals either because they
occur infrequently or in limited
geographic areas. Minor species are all
animals other than the major species; for
example, zoo animals, ornamental fish,
parrots, ferrets, and guinea pigs. Some
animals of agricultural importance are
also minor species. These include
animals such as sheep, goats, catfish,
and honeybees. Participation in the
MUMS program is completely optional
for drug sponsors so the associated
paperwork only applies to those
sponsors who request and are
subsequently granted ‘‘MUMS
designation.’’ The rule specifies the
criteria and procedures for requesting
MUMS designation as well as the
annual reporting requirements for
MUMS designees.
Section 516.20 (21 CFR 516.20)
provides requirements on the content
and format of a request for MUMS-drug
designation; § 516.26 (21 CFR 516.26)
provides requirements for amending
MUMS-drug designation; provisions for
change in sponsorship of MUMS-drug
designation can be found under § 516.27
(21 CFR 516.27); under § 516.29 (21 CFR
516.29) are provisions for termination of
MUMS-drug designation; under § 516.30
(21 CFR 516.30) are requirements for
annual reports from sponsor(s) of
MUMS-designated drugs; and under
§ 516.36 (21 CFR 516.36) are provisions
for insufficient quantities of MUMSdesignated drugs.
Description of Respondents:
Pharmaceutical companies that sponsor
new animal drugs.
In the Federal Register of July 2, 2013
(78 FR 39734), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
sroberts on DSK5SPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
516.20; Content and format of MUMS request ...................
516.26; Requirements for amending MUMS designation ...
516.27; Change in sponsorship ...........................................
VerDate Mar<15>2010
17:56 Nov 27, 2013
Jkt 232001
PO 00000
Frm 00063
Number of
responses per
respondent
15
3
1
Fmt 4703
Sfmt 4703
Total annual
responses
5
1
1
E:\FR\FM\29NON1.SGM
75
3
1
29NON1
Average
burden per
response
16
2
1
Total hours
1,200
6
1
]]>Agencies
[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71621-71623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28599]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1422]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Eye Tracking Study of Direct-to-Consumer Prescription
Drug Advertisement Viewing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Eye Tracking Study of
Direct-to-Consumer Prescription Drug Advertisement Viewing.'' This
study is designed to use eye tracking technology to explore how
consumers view direct-to-consumer (DTC) prescription drug
advertisements (ads) that include text regarding risk information and
reporting side effects and that vary in the amount of distracting audio
and visual content during the presentation of the risk information.
DATES: Submit either electronic or written comments on the collection
of information by January 28, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal
[[Page 71622]]
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Eye Tracking Study of Direct-to-Consumer Prescription Drug
Advertisement Viewing--(OMB Control Number 0910-NEW)
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
Current regulations require that a major statement of the risks of
prescription drugs be included in at least the audio of DTC television
ads. FDA has proposed including the risk information in DTC television
ads in superimposed text as well as in the audio (75 FR 15376,
``Direct-to-Consumer Prescription Drug Advertisements; Presentation of
the Major Statement in Television and Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner''). In addition, Title IX of the Food
and Drug Administration Amendments Act (Pub. L. 110-85) required a
study to determine if the statement ``You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088'' (the MedWatch statement)
is appropriate for inclusion in DTC television ads. These
communications have been tested separately by FDA. The first study
found that participants were better able to recall the drug risks when
they were presented in superimposed text as well as in audio (OMB
Control Number 0910-0634, ``Experimental Evaluation of the Impact of
Distraction''). The second study found that the inclusion of the
MedWatch statement does not interfere with participants' understanding
of the risk information (OMB Control Number 0910-0652,``Experimental
Study: Toll-Free Number for Consumer Reporting of Drug Product Side
Effects in Direct-to-Consumer Television Advertisements for
Prescription Drugs''). Thus, these two new communications may appear in
future DTC television ads. However, they have not been examined
together.
In addition, questions continue to arise about the use of
potentially distracting images and sounds during the major statement of
risks in DTC television ads. The first study referenced above found no
differences among ads that differed in the affective tone of static,
non-moving visuals presented during the major statement of risks.
Previous research has shown that factors such as multiple scene changes
and music in advertising can be distracting. However, the effects of
this kind of distraction during the major statement of risks on
consumers' perceptions and risk recall has not been tested in the
presence of risk reinforcing superimposed text.
This project is designed to use eye tracking technology to
determine how these communications in DTC ads are perceived and the
impact of distraction. Eye tracking technology is an effective method
to determine the extent to which consumers attend to risk information
presented in DTC television ads. This technology allows researchers to
unobtrusively detect and measure where a participant looks while
viewing a television ad and for how long, and the pattern of their eye
movements may indicate attention to and processing of information in
the ad.
We plan to collect descriptive eye tracking data on participants'
attention to (1) the superimposed text during the major statement of
risk information and (2) the MedWatch statement. Further, we plan to
examine experimentally the effect of distraction. We hypothesize that
distracting audio and visuals during the major statement will decrease
risk recall, risk perceptions, and attention to superimposed text risk
information. To test these hypotheses, we will conduct inferential
statistical tests such as analysis of variance. With the sample size
described below, we will have sufficient power to detect small- to
medium-sized effects in the main study.
We plan to conduct one 60-minute pilot study with 30 participants
and one 30-minute main study with 300 participants. All participants
will be 18 years of age or older who self-identify as needing to lose
more than 30 pounds. We will exclude individuals who work in healthcare
or marketing or who wear bifocals or hard contact lenses. The studies
will be conducted in person in at least five different cities across
the United States.
The pilot study and main study will have the same design and will
follow the same procedure. Participants will be randomly assigned to
one of three test conditions (low, medium, and high distraction in a
DTC television ad). The ad will be for a fictitious weight loss
prescription drug. The ads are currently being created and pretested to
ensure that consumers perceive different levels of distraction across
the ads (OMB Control Number 0910-0695, ``Stimuli Development and
Pretests for an Attentional Effects Study''). For instance, as the
distraction level increases, the number of scene changes and on-screen
activity during the major statement will increase.
We will explain the study procedure to participants and calibrate
the eye tracking device. To collect eye tracking data, we will use an
unobtrusive computer-interfaced eye tracker with a minimum speed of 60
Hertz. The test images will be shown on a computer monitor with a
minimum size of 20 inches and a minimum display resolution of 1,280 x
1,024. To simulate normal television ad viewing, participants will
watch a 2 to 5 minute video clip followed by a series of three ads. One
of the ads will be the study ad. The video clip and non-study ads will
be unrelated to health. The order of the ads will be counterbalanced,
and only eye tracking data from the study ad will be analyzed. Next,
participants will complete a questionnaire that assesses risk
perceptions, risk recall, recall of the MedWatch statement, and
covariates such as demographics and health literacy. In the pilot
study, participants will also answer questions as part of a debriefing
interview to assess the study design and questionnaire. The
questionnaire is available upon request.
FDA estimates the burden of this collection of information as
follows:
[[Page 71623]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Eye tracking study of DTC prescription drug Number of responses per Total annual Average burden per response Total hours
advertisement viewing respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study screener......................... 200 1 200 0.03 (2 minutes)......................... 6
Main study screener.......................... 2,000 1 2,000 0.03 (2 minutes)......................... 60
Pilot study.................................. 30 1 30 1........................................ 30
Main study................................... 300 1 300 0.50 (30 minutes)........................ 150
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 246
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28599 Filed 11-27-13; 8:45 am]
BILLING CODE 4160-01-P
